N/A
N=102
Saphenous Vein Cannulation in Infants and Small Children
Saphenous Vein Cannulation
Bottom Line
View on ClinicalTrials.gov: NCT01924975 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation — 51.0; 90.2 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Saphenous vein cannulation (Procedure); ultrasound with a linear transducer (L15-7io) (Device); A 22 or 24 G intravenous catheter (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Satoshi Hanada
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation |
51.0; 90.2 | — |
| SECONDARY Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period. |
62.8; 92.2 | — |
| SECONDARY Time Required for Overall Successful Venous Cannulation. |
235; 151 | — |
Summary
The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).
Eligibility Criteria
Inclusion Criteria
- Pediatric patient undergoing scheduled surgery which requires venous cannulation.
- Term neonates and children /= 3 kg
Exclusion Criteria
- Patient with visible saphenous vein
- Patient with no detectable saphenous vein under ultrasound
- Patient with a skin wound or infection around puncture site
- Patient with recent venous puncture at the puncture site (less than 1 month)
- Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound.
- Patient with any emergency surgery
Data sourced from ClinicalTrials.gov (NCT01924975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.